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Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries (TOBA II BTK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02942966
Recruitment Status : Completed
First Posted : October 24, 2016
Results First Posted : July 28, 2021
Last Update Posted : January 31, 2022
Sponsor:
Information provided by (Responsible Party):
Philips Clinical & Medical Affairs Global

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peripheral Arterial Disease
Intervention Device: Tack Endovascular System
Enrollment 233
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tack Endovascular System (4F)
Hide Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Period Title: Overall Study
Started 233 [1]
Completed 205 [2]
Not Completed 28
[1]
Intent to Treat (ITT) population.
[2]
Completed 6-month follow-up
Arm/Group Title Tack Endovascular System (4F)
Hide Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Baseline Participants 233
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 233 participants
74.4  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants
Female
76
  32.6%
Male
157
  67.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 233 participants
American Indian or Alaska Native
1
   0.4%
Asian
3
   1.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
39
  16.7%
White
187
  80.3%
More than one race
0
   0.0%
Unknown or Not Reported
3
   1.3%
BMI   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 231 participants
28.8  (5.6)
[1]
Measure Analysis Population Description: BMI is missing for two subjects.
BMI >= 30   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants
86
  37.2%
[1]
Measure Analysis Population Description: BMI is missing for two subjects.
ABI in treated limb   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 198 participants
0.74  (0.27)
[1]
Measure Description: The ratio of systolic blood pressure measured at the ankle to systolic blood pressure measured at the brachial artery in the arm.
[2]
Measure Analysis Population Description: ABI information is missing for some subjects. Values ≥1.3 are censored as non-compressible.
TBI in treated limb   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 117 participants
0.43  (0.23)
[1]
Measure Description: The ratio of systolic blood pressure measured at the toe to systolic blood pressure measured at the brachial artery.
[2]
Measure Analysis Population Description: TBI information is missing for some subjects
Rutherford Classification   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 Number Analyzed 233 participants
0
   0.0%
1 Number Analyzed 233 participants
0
   0.0%
2 Number Analyzed 233 participants
0
   0.0%
3 Number Analyzed 233 participants
38
  16.3%
4 Number Analyzed 233 participants
78
  33.5%
5 Number Analyzed 233 participants
117
  50.2%
6 Number Analyzed 233 participants
0
   0.0%
[1]
Measure Description:

Clinical scale identifying three grades of claudication and three grades of critical limb ischemia ranging from rest pain alone to minor and major tissue loss.

Class Clinical Description

0 Asymptomatic -no hemodynamically significant occlusive disease

  1. Mild claudication
  2. Moderate claudication
  3. Severe claudication
  4. Ischemic rest pain
  5. Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia
  6. Major tissue loss-extending above TM level, functional foot no longer salvageable
Wound Grade   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 Number Analyzed 233 participants
122
  52.4%
1 Number Analyzed 233 participants
91
  39.1%
modified 2 Number Analyzed 233 participants
20
   8.6%
2 Number Analyzed 233 participants
0
   0.0%
3 Number Analyzed 233 participants
0
   0.0%
[1]
Measure Description: Part of the WIfI Classification grading system created by the Society of Vascular Surgery (SVS). This system focuses on the three main factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Each of the three factors are graded on a scale from 0 to 3. The 0 represents none, 1-mild, 2-moderate and 3-severe. For the purpose of this study only, an additional Wound grade of modified 2 was added which permits some additional wounds to be included.
Ischemia Grade   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 Number Analyzed 221 participants
115
  52.0%
1 Number Analyzed 221 participants
55
  24.9%
2 Number Analyzed 221 participants
28
  12.7%
3 Number Analyzed 221 participants
23
  10.4%
[1]
Measure Description: Part of the WIfI Classification grading system created by the Society of Vascular Surgery (SVS). This system focuses on the three main factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Each of the three factors are graded on a scale from 0 to 3. The 0 represents none, 1-mild, 2-moderate and 3-severe.
[2]
Measure Analysis Population Description: Ischemia grade missing for some subjects
Foot Infection Grade   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
0 Number Analyzed 233 participants
194
  83.3%
1 Number Analyzed 233 participants
39
  16.7%
2 Number Analyzed 233 participants
0
   0.0%
3 Number Analyzed 233 participants
0
   0.0%
[1]
Measure Description: Part of the WIfI Classification grading system created by the Society of Vascular Surgery (SVS). This system focuses on the three main factors that impact amputation risk and clinical management: Wound, Ischemia, and foot Infection (WIfI). Each of the three factors are graded on a scale from 0 to 3. The 0 represents none, 1-mild, 2-moderate and 3-severe.
1.Primary Outcome
Title Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days
Hide Description Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of evaluable subjects for the 6 Month Primacy Efficacy Endpoint was 209.
Arm/Group Title Tack Endovascular System (4F)
Hide Arm/Group Description:
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Participants Analyzed 209
Measure Type: Count of Participants
Unit of Measure: Participants
200
  95.7%
2.Primary Outcome
Title Safety - Number of Participants With MALE Plus POD at 30 Days
Hide Description Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Four subjects were not evaluable for the 30 Day primary safety endpoint due to missing the 30 day visit and no additional visits occurred beyond day 30. One subject was not evaluable for the 30 Day primary safety endpoint due to an early 30 day visit and no additional visits Day 30. These subjects were therefore not included in the denominator for the primary safety endpoint analysis.
Arm/Group Title Tack Endovascular System (4F)
Hide Arm/Group Description:
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Participants Analyzed 228
Measure Type: Count of Participants
Unit of Measure: Participants
3
   1.3%
3.Secondary Outcome
Title Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months
Hide Description Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Some subjects had Tack implants placed in multiple lesions
Arm/Group Title Tack Endovascular System (4F)
Hide Arm/Group Description:
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Participants Analyzed 233
Overall Number of Units Analyzed
Type of Units Analyzed: Number of lesions
303
Measure Type: Number
Unit of Measure: number of lesions
248
4.Secondary Outcome
Title Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months
Hide Description Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
The number of evaluable subjects for Target Limb Salvage at 6 Months was 209.
Arm/Group Title Tack Endovascular System (4F)
Hide Arm/Group Description:
Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
Overall Number of Participants Analyzed 209
Measure Type: Count of Participants
Unit of Measure: Participants
206
  98.6%
Time Frame Summary of adverse events that have been reported through 210 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tack Endovascular System (4F)
Hide Arm/Group Description Use of the Tack Endovascular System (4F) in the mid/distal popliteal, tibial and peroneal arteries ranging in diameter from 1.5mm to 4.5mm for the repair of post percutaneous transluminal balloon angioplasty (PTA) dissection(s).
All-Cause Mortality
Tack Endovascular System (4F)
Affected / at Risk (%)
Total   63/233 (27.04%)    
Hide Serious Adverse Events
Tack Endovascular System (4F)
Affected / at Risk (%) # Events
Total   179/233 (76.82%)    
Blood and lymphatic system disorders   
Anemia   4/233 (1.72%)  4
Microcytic anemia   1/233 (0.43%)  1
Cardiac disorders   
Acute on chronic heart failure   2/233 (0.86%)  3
Angina at rest   1/233 (0.43%)  1
Angina pectoris   1/233 (0.43%)  1
Aortic valve stenosis   2/233 (0.86%)  2
Atrial fibrillation   1/233 (0.43%)  1
Bradycardia   1/233 (0.43%)  2
Cardiac failure aggravated   1/233 (0.43%)  1
Cardiomyopathy   1/233 (0.43%)  1
Congestive heart failure   2/233 (0.86%)  2
Coronary artery disease   1/233 (0.43%)  1
Coronary artery stenosis   1/233 (0.43%)  1
Coronary heart disease   1/233 (0.43%)  1
Decompensated heart failure   1/233 (0.43%)  1
Decompensation cardiac   3/233 (1.29%)  3
Heart failure   2/233 (0.86%)  2
Heart failure NYHA class III   1/233 (0.43%)  1
Heart insufficiency   2/233 (0.86%)  2
Myocardial infarction   2/233 (0.86%)  2
New onset angina pectoris   1/233 (0.43%)  1
Non ST segment elevation myocardial infarction   3/233 (1.29%)  3
Paroxysmal atrial fibrillation   1/233 (0.43%)  1
Progressive angina   1/233 (0.43%)  1
Right coronary artery stenosis   1/233 (0.43%)  1
ST segment elevation myocardial infarction   1/233 (0.43%)  1
Supraventricular tachycardia   1/233 (0.43%)  1
Ear and labyrinth disorders   
Supraventricular tachycardia   1/233 (0.43%)  1
Gastrointestinal disorders   
Abdominal pain   1/233 (0.43%)  2
Coprostasis   1/233 (0.43%)  1
Duodenal ulcer hemorrhage   1/233 (0.43%)  1
Gastrointestinal bleed   1/233 (0.43%)  1
Melena   1/233 (0.43%)  1
Nausea   1/233 (0.43%)  1
Oral hemorrhage   1/233 (0.43%)  1
Retroperitoneal hematoma   1/233 (0.43%)  1
Small bowel obstruction   1/233 (0.43%)  1
Ventral hernia   1/233 (0.43%)  1
General disorders   
Acute chest pain   1/233 (0.43%)  1
Chest pain   2/233 (0.86%)  2
Delayed healing of wound   2/233 (0.86%)  2
In-stent peripheral artery restenosis   3/233 (1.29%)  3
Opiate withdrawal symptoms   1/233 (0.43%)  1
Puncture site bleeding   1/233 (0.43%)  1
Sudden cardiac death   1/233 (0.43%)  1
Unknown cause of death   1/233 (0.43%)  1
Hepatobiliary disorders   
Acute cholecystitis   1/233 (0.43%)  1
Infections and infestations   
Bacteremia   1/233 (0.43%)  1
Bacteriuria   1/233 (0.43%)  1
Cellulitis of toe   1/233 (0.43%)  1
Clostridial gastroenteritis   1/233 (0.43%)  1
Erysipelas   1/233 (0.43%)  1
Gangrene   1/233 (0.43%)  2
Gangrene peripheral   2/233 (0.86%)  4
Gangrene toe   5/233 (2.15%)  6
Infection of amputation stump   1/233 (0.43%)  1
Osteomyelitis of the foot   4/233 (1.72%)  5
Phlegmon   1/233 (0.43%)  1
Pneumonia, organism unspecified   4/233 (1.72%)  5
Postoperative infection   1/233 (0.43%)  1
Sepsis   2/233 (0.86%)  2
Soft tissue infection   1/233 (0.43%)  1
Spondylodiscitis   1/233 (0.43%)  2
Staphylococcus aureus bacteremia   1/233 (0.43%)  1
Urinary tract infection, site not specified   1/233 (0.43%)  1
Wet gangrene   1/233 (0.43%)  1
Injury, poisoning and procedural complications   
Abdominal wall wound   1/233 (0.43%)  1
Chronic subdural hematoma   1/233 (0.43%)  1
Femoral artery pseudoaneurysm   1/233 (0.43%)  1
Fracture femur   1/233 (0.43%)  1
Fracture of neck of femur   1/233 (0.43%)  1
Overdose NOS   1/233 (0.43%)  1
Peripheral arterial reocclusion   4/233 (1.72%)  6
Peripheral artery restenosis   4/233 (1.72%)  4
Pseudoaneurysm   2/233 (0.86%)  2
Skin tear   2/233 (0.86%)  2
Traumatic brain injury   1/233 (0.43%)  1
Vascular access site bleeding   1/233 (0.43%)  1
Wound   1/233 (0.43%)  2
Wound bleeding   1/233 (0.43%)  1
Metabolism and nutrition disorders   
Gout aggravated   1/233 (0.43%)  1
Hyperglycemia   3/233 (1.29%)  3
Hyperkalemia   1/233 (0.43%)  1
Hypokalemia   1/233 (0.43%)  1
Hyponatremia   1/233 (0.43%)  4
Type II diabetes mellitus inadequate control   1/233 (0.43%)  1
Musculoskeletal and connective tissue disorders   
Coxarthrosis   1/233 (0.43%)  1
Hyperuricemic arthritis   1/233 (0.43%)  1
Leg pain   1/233 (0.43%)  1
Polyarthritis   1/233 (0.43%)  1
Prepatellar bursitis   1/233 (0.43%)  1
Soft tissue disorder   1/233 (0.43%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basalioma   1/233 (0.43%)  1
Diffuse large B-cell lymphoma recurrent   1/233 (0.43%)  1
Leukemia   1/233 (0.43%)  1
Liver carcinoma   1/233 (0.43%)  1
Ovarian granulosa cell tumor   1/233 (0.43%)  1
Nervous system disorders   
Ataxia   1/233 (0.43%)  1
Bleeding intracranial   1/233 (0.43%)  1
Carotid artery stenosis   2/233 (0.86%)  2
Dizziness   1/233 (0.43%)  1
Drop attacks   1/233 (0.43%)  1
Focal epilepsy   1/233 (0.43%)  1
Stroke   2/233 (0.86%)  2
Syncopal attack   1/233 (0.43%)  1
TIA   1/233 (0.43%)  1
Transient ischemic attack   1/233 (0.43%)  1
Psychiatric disorders   
Confusion   1/233 (0.43%)  1
Hyperactive delirium   1/233 (0.43%)  1
Transient psychosis   1/233 (0.43%)  1
Renal and urinary disorders   
Acute kidney injury   3/233 (1.29%)  3
Acute on chronic renal failure   2/233 (0.86%)  2
Acute renal failure   4/233 (1.72%)  4
Renal failure   1/233 (0.43%)  1
Reproductive system and breast disorders   
Metrorrhagia   1/233 (0.43%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure   1/233 (0.43%)  1
Bilateral pleural effusion   2/233 (0.86%)  2
Dyspnea   1/233 (0.43%)  1
Hypoxia   1/233 (0.43%)  1
Lung edema   1/233 (0.43%)  1
Shortness of breath   1/233 (0.43%)  1
Skin and subcutaneous tissue disorders   
Chronic leg ulcer   1/233 (0.43%)  1
Diabetic foot   1/233 (0.43%)  2
Digital ulcer   2/233 (0.86%)  2
Rash   1/233 (0.43%)  1
Ulcer foot   1/233 (0.43%)  1
Venous ulceration   1/233 (0.43%)  1
Surgical and medical procedures   
Medical device battery replacement   1/233 (0.43%)  1
Vascular disorders   
Abdominal aortic aneurysm   1/233 (0.43%)  1
Acute limb ischemia   2/233 (0.86%)  2
Anterior tibial artery perforation   1/233 (0.43%)  1
Arterial occlusion   1/233 (0.43%)  1
Arterial stenosis   1/233 (0.43%)  1
Atherosclerosis of arteries of the extremities   1/233 (0.43%)  1
Claudication   8/233 (3.43%)  10
Critical limb ischemia   3/233 (1.29%)  3
Digital necrosis   1/233 (0.43%)  1
Dry gangrene foot   1/233 (0.43%)  2
Dry gangrene toe   1/233 (0.43%)  1
Extremity necrosis   1/233 (0.43%)  1
Hematoma   1/233 (0.43%)  1
Hypertension   1/233 (0.43%)  1
Hypotension   3/233 (1.29%)  3
Iliac artery stenosis   1/233 (0.43%)  1
Internal hemorrhage   1/233 (0.43%)  1
Ischemic limb pain   1/233 (0.43%)  1
Peripheral arterial occlusive disease   1/233 (0.43%)  1
Peripheral arterial occlusive disease Fontaine stage IV   1/233 (0.43%)  1
Peripheral arterial occlusive disease aggravated   4/233 (1.72%)  5
Peripheral artery occlusion   1/233 (0.43%)  1
Peripheral artery thrombosis   1/233 (0.43%)  1
Peripheral vascular disease   9/233 (3.86%)  10
Peripheral vascular disease   1/233 (0.43%)  1
Superficial femoral arterial stenosis   1/233 (0.43%)  1
Superficial femoral artery occlusion   1/233 (0.43%)  1
Uncontrolled hypertension   1/233 (0.43%)  1
Varicose vein   1/233 (0.43%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tack Endovascular System (4F)
Affected / at Risk (%) # Events
Total   137/233 (58.80%)    
Blood and lymphatic system disorders   
Anemia   4/233 (1.72%)  4
Microcytic anemia   1/233 (0.43%)  1
Cardiac disorders   
Acute on chronic heart failure   2/233 (0.86%)  3
Angina at rest   1/233 (0.43%)  1
Angina pectoris   1/233 (0.43%)  1
Aortic valve stenosis   2/233 (0.86%)  2
Atrial fibrillation   1/233 (0.43%)  1
Bradycardia   1/233 (0.43%)  2
Cardiac failure aggravated   1/233 (0.43%)  1
Congestive heart failure   2/233 (0.86%)  2
Coronary artery disease   1/233 (0.43%)  1
Coronary artery stenosis   1/233 (0.43%)  1
Coronary heart disease   1/233 (0.43%)  1
Decompensated heart failure   1/233 (0.43%)  1
Decompensation cardiac   3/233 (1.29%)  3
Heart failure   2/233 (0.86%)  2
Heart failure NYHA class III   1/233 (0.43%)  1
Heart insufficiency   2/233 (0.86%)  2
Ischaemic heart disease   1/233 (0.43%)  1
Myocardial infarction   2/233 (0.86%)  2
New onset angina pectoris   1/233 (0.43%)  1
Non ST segment elevation myocardial infarction   3/233 (1.29%)  3
Paroxysmal atrial fibrillation   1/233 (0.43%)  1
Progressive angina   1/233 (0.43%)  1
Right coronary artery stenosis   1/233 (0.43%)  1
ST segment elevation myocardial infarction   1/233 (0.43%)  1
Supraventricular tachycardia   1/233 (0.43%)  1
Ear and labyrinth disorders   
Meniere's disease aggravated   1/233 (0.43%)  1
Gastrointestinal disorders   
Abdominal pain   1/233 (0.43%)  2
Coprostasis   1/233 (0.43%)  1
Duodenal ulcer hemorrhage   1/233 (0.43%)  1
Gastrointestinal bleed   1/233 (0.43%)  1
Gastrointestinal bleeding   2/233 (0.86%)  2
Melena   2/233 (0.86%)  2
Nausea   1/233 (0.43%)  1
Oral hemorrhage   1/233 (0.43%)  1
Retroperitoneal hematoma   1/233 (0.43%)  1
Small bowel obstruction   1/233 (0.43%)  1
Ventral hernia   1/233 (0.43%)  1
General disorders   
Acute chest pain   1/233 (0.43%)  1
Chest pain   2/233 (0.86%)  2
Delayed healing of wound   3/233 (1.29%)  3
In-stent peripheral artery restenosis   3/233 (1.29%)  3
Leg edema   2/233 (0.86%)  2
Opiate withdrawal symptoms   1/233 (0.43%)  1
Puncture site bleeding   1/233 (0.43%)  1
Swelling of limb   1/233 (0.43%)  1
Hepatobiliary disorders   
Acute cholecystitis   1/233 (0.43%)  1
Infections and infestations   
Bacteremia   1/233 (0.43%)  1
Bacteriuria   1/233 (0.43%)  1
Cellulitis of toe   1/233 (0.43%)  1
Clostridial gastroenteritis   1/233 (0.43%)  1
Erysipelas   1/233 (0.43%)  1
Gangrene   1/233 (0.43%)  2
Gangrene peripheral   3/233 (1.29%)  5
Gangrene toe   5/233 (2.15%)  6
Infection of amputation stump   1/233 (0.43%)  1
Osteomyelitis of the foot   4/233 (1.72%)  5
Phlegmon   1/233 (0.43%)  1
Pneumonia, organism unspecified   4/233 (1.72%)  5
Postoperative infection   1/233 (0.43%)  1
Sepsis   2/233 (0.86%)  2
Soft tissue infection   1/233 (0.43%)  1
Spondylodiscitis   1/233 (0.43%)  2
Staphylococcus aureus bacteremia   1/233 (0.43%)  1
Urinary tract infection, site not specified   1/233 (0.43%)  1
Vascular access site infection   1/233 (0.43%)  1
Wet gangrene   1/233 (0.43%)  1
Injury, poisoning and procedural complications   
Abdominal wall wound   1/233 (0.43%)  1
Chronic subdural hematoma   1/233 (0.43%)  1
Femoral artery pseudoaneurysm   1/233 (0.43%)  1
Fracture femur   1/233 (0.43%)  1
Fracture of neck of femur   1/233 (0.43%)  1
Overdose NOS   1/233 (0.43%)  1
Peripheral arterial reocclusion   8/233 (3.43%)  10
Peripheral artery restenosis   9/233 (3.86%)  10
Post procedural bleeding   1/233 (0.43%)  1
Post procedural complication   4/233 (1.72%)  4
Post procedural hematoma   3/233 (1.29%)  3
Pseudoaneurysm   5/233 (2.15%)  5
Skin tear   1/233 (0.43%)  1
Traumatic brain injury   1/233 (0.43%)  1
Vascular access site bleeding   1/233 (0.43%)  1
Vascular access site hematoma   2/233 (0.86%)  2
Wound   3/233 (1.29%)  4
Wound bleeding   1/233 (0.43%)  1
Metabolism and nutrition disorders   
Gout aggravated   1/233 (0.43%)  1
Hyperglycemia   3/233 (1.29%)  3
Hyperkalemia   1/233 (0.43%)  1
Hypokalemia   1/233 (0.43%)  1
Hyponatremia   1/233 (0.43%)  4
Type II diabetes mellitus inadequate control   1/233 (0.43%)  1
Musculoskeletal and connective tissue disorders   
Coxarthrosis   1/233 (0.43%)  1
Hyperuricemic arthritis   1/233 (0.43%)  1
Leg pain   2/233 (0.86%)  2
Pain of lower extremities   1/233 (0.43%)  1
Polyarthritis   1/233 (0.43%)  1
Prepatellar bursitis   1/233 (0.43%)  1
Soft tissue disorder   1/233 (0.43%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basalioma   1/233 (0.43%)  1
Diffuse large B-cell lymphoma recurrent   1/233 (0.43%)  1
Leukemia   1/233 (0.43%)  2
Liver carcinoma   1/233 (0.43%)  1
Ovarian granulosa cell tumor   1/233 (0.43%)  1
Nervous system disorders   
Ataxia   1/233 (0.43%)  1
Bleeding intracranial   1/233 (0.43%)  1
Carotid artery stenosis   2/233 (0.86%)  2
Dizziness   1/233 (0.43%)  1
Drop attacks   1/233 (0.43%)  1
Focal epilepsy   1/233 (0.43%)  1
Stroke   2/233 (0.86%)  2
Syncopal attack   1/233 (0.43%)  1
TIA   1/233 (0.43%)  1
Transient ischemic attack   1/233 (0.43%)  1
Psychiatric disorders   
Confusion   1/233 (0.43%)  1
Hyperactive delirium   1/233 (0.43%)  1
Transient psychosis   1/233 (0.43%)  1
Renal and urinary disorders   
Acute kidney injury   3/233 (1.29%)  3
Acute on chronic renal failure   2/233 (0.86%)  2
Acute renal failure   4/233 (1.72%)  4
Renal failure   1/233 (0.43%)  1
Metrorrhagia   1/233 (0.43%)  1
Respiratory, thoracic and mediastinal disorders   
Acute respiratory failure   1/233 (0.43%)  1
Bilateral pleural effusion   2/233 (0.86%)  2
Dyspnea   1/233 (0.43%)  1
Hypoxia   1/233 (0.43%)  1
Lung edema   1/233 (0.43%)  1
Shortness of breath   1/233 (0.43%)  1
Skin and subcutaneous tissue disorders   
Chronic leg ulcer   1/233 (0.43%)  1
Diabetic foot   1/233 (0.43%)  2
Digital ulcer   2/233 (0.86%)  2
Rash   1/233 (0.43%)  1
Ulcer foot   1/233 (0.43%)  1
Venous ulceration   1/233 (0.43%)  1
Surgical and medical procedures   
Medical device battery replacement   1/233 (0.43%)  1
Peripheral arterial occlusive disease Fontaine stage IV   1/233 (0.43%)  1
Vascular disorders   
Abdominal aortic aneurysm   1/233 (0.43%)  1
Acute limb ischemia   2/233 (0.86%)  2
Anterior tibial artery perforation   1/233 (0.43%)  1
Arterial occlusion   1/233 (0.43%)  1
Arterial spasm   1/233 (0.43%)  1
Arterial stenosis   2/233 (0.86%)  2
Arteriovenous fistula   1/233 (0.43%)  1
Artery dissection   1/233 (0.43%)  1
Atherosclerosis of arteries of the extremities   1/233 (0.43%)  1
Claudication   8/233 (3.43%)  10
Critical limb ischemia   3/233 (1.29%)  3
Deep vein thrombosis leg   1/233 (0.43%)  1
Digital necrosis   3/233 (1.29%)  3
Dry gangrene foot   1/233 (0.43%)  2
Dry gangrene toe   1/233 (0.43%)  1
Extremity necrosis   1/233 (0.43%)  1
Hematoma   1/233 (0.43%)  1
Hypertension   1/233 (0.43%)  1
Hypotension   3/233 (1.29%)  3
Iliac artery stenosis   1/233 (0.43%)  1
Internal hemorrhage   1/233 (0.43%)  1
Ischemic limb pain   1/233 (0.43%)  1
Peripheral arterial occlusive disease   1/233 (0.43%)  1
Peripheral arterial occlusive disease aggravated   5/233 (2.15%)  6
Peripheral artery occlusion   1/233 (0.43%)  1
Peripheral artery thrombosis   1/233 (0.43%)  1
Peripheral embolism   1/233 (0.43%)  1
Peripheral vascular disease   9/233 (3.86%)  10
Popliteal artery occlusion   1/233 (0.43%)  1
Reperfusion injury   2/233 (0.86%)  2
Superficial femoral arterial stenosis   1/233 (0.43%)  1
Superficial femoral artery occlusion   1/233 (0.43%)  1
Thrombosis   2/233 (0.86%)  2
Tibial artery occlusion   1/233 (0.43%)  1
Tibial artery stenosis   1/233 (0.43%)  1
Tibial artery thrombosis   1/233 (0.43%)  1
Uncontrolled hypertension   1/233 (0.43%)  1
Varicose vein   1/233 (0.43%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI acknowledges that Clinical Trial is part of multi-center clinical study. Publication of multi-center data requires prior review and consent of both Sponsor and all participating sites. PI agrees that the first publication of the results of the Clinical Trial shall be made in conjunction with results from other participating sites. Provided, however, that if no multi-center publication is made within one year from database lock, then PI may publish individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nicolas Aguirre
Organization: Philips Image Guided Therapy
Phone: (612) 297-6655
EMail: nicolas.aguirre@philips.com
Layout table for additonal information
Responsible Party: Philips Clinical & Medical Affairs Global
ClinicalTrials.gov Identifier: NCT02942966    
Other Study ID Numbers: CA 0137
First Submitted: October 20, 2016
First Posted: October 24, 2016
Results First Submitted: April 2, 2021
Results First Posted: July 28, 2021
Last Update Posted: January 31, 2022